Response to Influenza Vaccination in Pediatric Oncology Patients

Pediatric Cancer Clinical Trial

Official title:

Response to Influenza Vaccination in Pediatric Oncology Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05384288
• Other study ID #: RIVIPOP
• Status: Recruiting
• Start date: October 7, 2022
• Est. completion date: December 2027

Study information

• Verified date: October 2023
• Source: St. Jude Children's Research Hospital
• Contact: Ramilo Octavio, MD
• Phone: 866-278-5833
• Email: referralinfo[@]stjude.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Influenza infection occurring during oncologic treatment or following hematopoietic cell transplantation (HCT) is associated with increased risk of morbidity in the form of lower respiratory tract infection (LRTI) and mortality relative to otherwise healthy patients. The study participants have been diagnosed with a hematological malignancy and are eligible to receive the current seasonal influenza (Flu) vaccine.

Primary Objective

• To determine the feasibility of opening a longitudinal prospective study of IIV immunogenicity in pediatric leukemia patients.

• To describe the immunogenicity, as measured by the development of cell- and/or antibody-mediated influenza specific responses 3 to 5 weeks following vaccination, in a cohort of pediatric leukemia patients.

Secondary Objectives

• To describe whether an immune response, as measured by development of cell- and/or antibody-mediated influenza specific responses, is detectable 1-2 weeks following vaccination in a cohort of pediatric leukemia patients.

• To describe the durability of immunogenicity by measuring cell - and antibody- mediated influenza specific responses at 6 months and 1 year following vaccination in a cohort of pediatric leukemia patients.

Exploratory Objectives

• To estimate the clinical effectiveness of influenza vaccine in this cohort by monitoring for the development of clinical diagnosis of influenza in the cohort of enrolled pediatric oncology patients.

• To correlate results of immune cell frequency in blood, as measured by complete blood count with differential, with development of an immune response to IIV.

Description:

This is a prospective, 2-stage, non-therapeutic study to characterize the immunogenicity of influenza vaccination among pediatric oncology patients at St. Jude. The first stage of the study will consist of a feasibility phase to assess the feasibility of opening a longitudinal prospective study of IIV immunogenicity in pediatric leukemia patients. The second stage will assess the immunogenicity of IIV among pediatric leukemia patients in a larger samples size. The investigator will collect about one teaspoon of blood from the study participant up to 6 times over a year for a total of 6 teaspoons a year. The investigator will also collect some information about the study participant's underlying condition, flu testing and overall health from the medical record during this time.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 113
• Est. completion date: December 2027
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Patient = 18 years old at the time of consent receiving care at St. Jude Children's Research Hospital

• Diagnosed with a hematological malignancy

• Eligible to receive the current seasonal influenza vaccine

Exclusion Criteria:

• Previously received at least one dose of the current seasonal influenza vaccine.

Related Conditions & MeSH terms

• Hematologic Malignancy
• Hematologic Neoplasms
• Influenza, Human
• Pediatric Cancer
• Transplant-Related Cancer

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of evaluable participants.	Feasibility is estimated as the proportion of evaluable patients who provide a baseline and Day +35 sample. A 95% confidence interval will be provided.	3 years
Primary	Proportion of participants with immunogenicity 3 to 5 weeks following vaccination.	Immunogenecity will be measured by the development of cell- and antibody-mediated influenza specific responses 3 to 5 weeks following vaccination. Immunogenicity is estimated as the proportion of evaluable patients whose cell- (as measured by development of any detectable specific T cell responses) and antibody-mediated influenza specific responses (as measured by detectable post vaccination antibody titers) 3 to 5 weeks following vaccination. 95% confidence intervals will be provided.	3 years
Secondary	Proportion of participants with an immune response 1 to 2 weeks following vaccination.	The proportion of patients who have detectable cell- and antibody-mediated influenza specific responses 1-2 weeks following vaccination will be estimated along with a 95% confidence interval.	3 years
Secondary	Proportion of participants with durability of immunogenicity at 6 months and 1 year post-vaccination.	The proportion of patients who still have detectable cell- and antibody-mediated influenza specific responses 6 months and 1 year following vaccination will be estimated, respectively. 95% confidence intervals will be provided	3 years

External Links

•   Clinical Trials Open at St. Jude
•   St. Jude Children's Research Hospital